ES2636844T3 - Sistemas y marcadores de eventos ingeribles de comunicación multimodo, y métodos para usarlos - Google Patents
Sistemas y marcadores de eventos ingeribles de comunicación multimodo, y métodos para usarlos Download PDFInfo
- Publication number
- ES2636844T3 ES2636844T3 ES09717404.9T ES09717404T ES2636844T3 ES 2636844 T3 ES2636844 T3 ES 2636844T3 ES 09717404 T ES09717404 T ES 09717404T ES 2636844 T3 ES2636844 T3 ES 2636844T3
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- Prior art keywords
- iem
- communication module
- conductive communication
- antenna
- ingestible
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- 238000004891 communication Methods 0.000 title abstract description 23
- 238000000034 method Methods 0.000 title description 5
- 210000001124 body fluid Anatomy 0.000 abstract 1
- 239000010839 body fluid Substances 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 description 12
- 239000010410 layer Substances 0.000 description 5
- 239000008186 active pharmaceutical agent Substances 0.000 description 3
- 230000006870 function Effects 0.000 description 2
- 239000003550 marker Substances 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 238000012550 audit Methods 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 239000010406 cathode material Substances 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 239000004020 conductor Substances 0.000 description 1
- 238000002372 labelling Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000007726 management method Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
Classifications
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- H—ELECTRICITY
- H04—ELECTRIC COMMUNICATION TECHNIQUE
- H04B—TRANSMISSION
- H04B5/00—Near-field transmission systems, e.g. inductive or capacitive transmission systems
- H04B5/70—Near-field transmission systems, e.g. inductive or capacitive transmission systems specially adapted for specific purposes
- H04B5/77—Near-field transmission systems, e.g. inductive or capacitive transmission systems specially adapted for specific purposes for interrogation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00002—Operational features of endoscopes
- A61B1/00011—Operational features of endoscopes characterised by signal transmission
- A61B1/00016—Operational features of endoscopes characterised by signal transmission using wireless means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/04—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor combined with photographic or television appliances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/07—Endoradiosondes
- A61B5/073—Intestinal transmitters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4833—Assessment of subject's compliance to treatment
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
- A61B5/4839—Diagnosis combined with treatment in closed-loop systems or methods combined with drug delivery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/48—Other medical applications
- A61B5/4848—Monitoring or testing the effects of treatment, e.g. of medication
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/6861—Capsules, e.g. for swallowing or implanting
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06K—GRAPHICAL DATA READING; PRESENTATION OF DATA; RECORD CARRIERS; HANDLING RECORD CARRIERS
- G06K7/00—Methods or arrangements for sensing record carriers, e.g. for reading patterns
- G06K7/10—Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation
- G06K7/10009—Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation sensing by radiation using wavelengths larger than 0.1 mm, e.g. radio-waves or microwaves
- G06K7/10297—Methods or arrangements for sensing record carriers, e.g. for reading patterns by electromagnetic radiation, e.g. optical sensing; by corpuscular radiation sensing by radiation using wavelengths larger than 0.1 mm, e.g. radio-waves or microwaves arrangements for handling protocols designed for non-contact record carriers such as RFIDs NFCs, e.g. ISO/IEC 14443 and 18092
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/08—Sensors provided with means for identification, e.g. barcodes or memory chips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
- A61B2562/162—Capsule shaped sensor housings, e.g. for swallowing or implantation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0031—Implanted circuitry
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Physics & Mathematics (AREA)
- Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Pathology (AREA)
- Heart & Thoracic Surgery (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Biomedical Technology (AREA)
- Animal Behavior & Ethology (AREA)
- Biophysics (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Computer Networks & Wireless Communication (AREA)
- Toxicology (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Signal Processing (AREA)
- Radiology & Medical Imaging (AREA)
- Optics & Photonics (AREA)
- Artificial Intelligence (AREA)
- Theoretical Computer Science (AREA)
- General Physics & Mathematics (AREA)
- Computer Vision & Pattern Recognition (AREA)
- Electromagnetism (AREA)
- Computer Security & Cryptography (AREA)
- Medical Treatment And Welfare Office Work (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Near-Field Transmission Systems (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Analysing Materials By The Use Of Radiation (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Abstract
Un dispositivo (102) que comprende: un componente ingerible que comprende un circuito integrado (206) que comprende un primer módulo de comunicación conductiva configurado para generar y emitir una primera señal, en donde la primera señal es una señal conductiva de campo cercano que se comunica por medio de un protocolo de comunicación conductiva que usa fluido corporal como medio de conducción; y un segundo módulo de comunicación no conductiva configurado para generar y emitir una segunda señal, en donde la segunda señal se comunica por medio de un protocolo de comunicación no conductiva; en donde el primer módulo de comunicación conductiva está separado del segundo módulo de comunicación no conductiva.
Description
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electrodo flexible). El chip pequeño 606 tiene, por ejemplo, entre 10 micrómetros y 10 milímetros en un lado, tal como de 100 micrómetros a 5 milímetros, p. ej. un milímetro en un lado, que tiene un cátodo en un primer lado (no se muestra) y un ánodo en un segundo lado (no se muestra). El chip 606 se incrusta en un faldón 608 por el que se genera trasmisión conductiva por corriente de modulación. Una antena 504 discurre a lo largo de, es decir, se asocia con, el perímetro del chip 606. La antena 504 incluye, por ejemplo, una antena multiespira/multicapa que actúa como antena para un enlace de RFID. En una realización, la antena es relativamente pequeña. En diversas realizaciones, se introduce una capa aislante (no se muestra) sobre la antena 504 para extender el alcance. Por ejemplo, la capa aislante incluye varios cientos de micrómetros de plástico sobre la antena 504. De esta manera, la unidad de RFID farmacéutica 602 es compacta, y por lo tanto fácilmente ingerible/implantable mientras todavía es operable en un intervalo de comunicación aceptable. En diversas otras realizaciones, la antena 504 coincide con un índice refractivo del cuerpo. De esta manera, la antena de RFID facilita comunicaciones intercuerpo, intracuerpo y extracuerpo.
El segundo módulo de RFID 604 se configura en asociación con un chip pequeño 606 que tiene una capa de cátodo (no se muestra) en la parte superior del chip 606. La capa de metal tiene un patrón con la antena 504, p. ej., densamente en patrón con la antena 504 que tiene un diseño multivuelta en espiral. La capa de metal tiene rendijas cortadas en la misma, tales como único corte de rendija en espiral.
Cuando se deposita el material de cátodo, la antena 504 sirve como conductor que proporciona el sustrato para conectar el cátodo y también colector de corriente para extraer energía eléctrica de ella. De esta manera, la antena 504 se acorta cuando está húmeda, permitiendo así que el módulo de RFID funcione en un ambiente seco (fabricación, farmacia, etc.) pero no en ambiente líquido, p. ej., dentro del cuerpo. Esto promueve la privacidad al inhabilitar comunicaciones de RFID con el sistema informático farmacéutico en el ciclo vital mientras está en el cuerpo.
En diversas realizaciones, la antena 504 se configura según cualquier patrón y/o ubicación respectivos al sistema informático farmacéutico en el ciclo vital. Patrones incluyen, por ejemplo, espirales, garabatos, curvas, multicurvas, rectas, curvadas, única capa, multicapa, y otros diseños y combinaciones de diseños.
La figura 9 muestra un identificador de marcador de evento ingerible que incluye un módulo de comunicación RFID, según una realización. En la figura 9, el identificador IEM 900 incluye componente de circuito integrado 910 y faldón
920. El componente de circuito integrado 910 incluye un módulo de comunicación conductiva y un módulo de comunicación RFID. El identificador 910 también incluye antena de RFID 930.
Identificadores de IEM que incluyen módulos de comunicación conductiva y módulos de comunicación no conductiva, tales como módulos de comunicaciones RFID, encuentran uso en una variedad de diferentes aplicaciones que pueden abarcar la vida útil del producto de un marcador de evento ingerible. Capacidades y funcionalidades proporcionadas por tales identificadores incluyen, pero no se limitan a: lectura de información de identificador IEM y almacenar información de pedigrí de uno o más de la fase de fabricación de IEM, fase de cadena de suministro, fase de gestión de farmacia y fase de uso por el paciente. Se pueden obtener fácilmente pedigrís completos para un IEM dado, de fabricación a uso y/o eliminación. Se puede proporcionar capacidad de auditoría en cada punto en la cadena de suministro. Se pueden emplear puestas de clasificación automatizada y firmas criptográficas para verificar autenticidad de producto, según se desee.
Dispositivos IEM que incluyen módulos de comunicación conductiva y de comunicación no conductiva se pueden fabricar usando cualquier protocolo de fabricación conveniente. En algunos casos, el protocolo de fabricación que se emplea es un protocolo de fabricación de alta producción. Tales protocolos de fabricación de alta producción incluyen, pero no se limitan a, los descritos en la solicitud provisional de Estados Unidos n.º de serie 61/142.849. Un protocolo de fabricación de alta producción en el que el IEM incluye un identificador que tiene ambos módulos de comunicación conductiva y de RFID y un portador de tableta fisiológicamente aceptable que incluye un agente farmacéutico activo se ilustra esquemáticamente en la figura 10. El proceso 1000 ilustrado en la figura 10 empieza con un identificador IEM 1010 que incluye un módulo de comunicación conductiva y de RFID (tal como el identificador ilustrado en la figura 9) que se combina con un agente farmacéutico activo (API) y un vehículo fisiológicamente aceptable 1020 en un IEM en tableta en la fase 1030. Tras la compresión en tableta, la tableta resultante puede ser recubierta en la fase 1040 y aplicar cualquier impresión o etiquetado en la fase 1050 para producir el IEM final. A continuación, el IEM se envía a la fase de empaquetado voluminoso 1060, donde el paquete voluminoso resultante de IEM es enviado en la fase 1070 a la farmacia 1080 para la venta final a un cliente. El cuadrado 1090 ilustra ejemplos de puntos en el proceso donde el módulo de comunicación RFID puede ser empleado para transmitir información al IEM y/o recibir información del IEM. Por ejemplo, puede trasmitirse información de programación al IEM por medio del módulo de comunicación RFID en cualquier de los puntos 1092, 1094, 1096 y 1098. Como alternativa y/o además de trasmitir información de programación al IEM por medio del módulo de comunicación RFID en cualquiera de los puntos 1092, 1094, 1096 y 1098, se puede recuperar información de identificación del IEM en cualquiera de estos puntos, p. ej., para facilitar empaquetado, clasificación, manejo, etc.
La figura 11 proporciona una vista de un dispositivo clasificador que incluye un receptor/transmisor de RFID, donde el dispositivo clasificador puede ser usado en un sistema de fabricación y cadena de suministro y/o farmacia (por ejemplo en cualquiera de los puntos 1092, 1094, 1096 y 1098. En la figura 11, la tolva 1100 incluye un número más
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salir del alcance de la presente invención. Cualquier método citado se puede llevar a cabo en el orden de eventos citados o en cualquier otro orden que sea lógicamente posible.
Aunque la invención precedente se ha descrito con cierto detalle a modo de ilustración y ejemplo por motivos de claridad y entendimiento, para los expertos en la técnica a la luz de las enseñanzas de esta invención será 5 fácilmente evidente que a la misma se le pueden hacer ciertos cambios y modificaciones sin salir del alcance de las reivindicaciones anexas.
Por consiguiente, lo anterior meramente ilustra los principios de la invención. Se apreciará que los expertos en la técnica podrán idear diversas disposiciones que, aunque no explícitamente descritas o mostradas en esta memoria, plasman los principios de la invención y se incluyen dentro de su espíritu y alcance. Además, todos los ejemplos y el 10 lenguaje condicional citado en esta memoria pretenden principalmente ayudar al lector a entender los principios de la invención y los conceptos contribuidos por los inventores para impulsar la técnica, y se han de interpretar como sin limitación a tales ejemplos y condiciones citados específicamente. Además, todas declaraciones en esta memoria que citan principios, aspectos, y realizaciones de la invención así como ejemplos específicos de al misma, pretenden abarcar equivalentes estructurales y funcionales de la misma. Adicionalmente, se pretende que tales equivalentes
15 incluyan ambos equivalentes conocidos actualmente y equivalentes desarrollados en el futuro, es decir, elementos desarrollados que realizan la misma función, independientemente de estructura. El alcance de la presente invención, por lo tanto, no pretende estar limitado a las realizaciones ejemplares mostradas y descritas en esta memoria. En cambio, el alcance de presente invención es plasmado por las reivindicaciones anexas.
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Claims (1)
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imagen1 imagen2
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US3408508P | 2008-03-05 | 2008-03-05 | |
| US34085P | 2008-03-05 | ||
| PCT/US2009/036231 WO2009111664A2 (en) | 2008-03-05 | 2009-03-05 | Multi-mode communication ingestible event markers and systems, and methods of using the same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| ES2636844T3 true ES2636844T3 (es) | 2017-10-09 |
| ES2636844T8 ES2636844T8 (es) | 2017-12-21 |
Family
ID=41056656
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES17170017T Active ES2840773T3 (es) | 2008-03-05 | 2009-03-05 | Sistemas y marcadores de eventos ingeribles de comunicación multimodo |
| ES09717404.9T Active ES2636844T3 (es) | 2008-03-05 | 2009-03-05 | Sistemas y marcadores de eventos ingeribles de comunicación multimodo, y métodos para usarlos |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES17170017T Active ES2840773T3 (es) | 2008-03-05 | 2009-03-05 | Sistemas y marcadores de eventos ingeribles de comunicación multimodo |
Country Status (14)
| Country | Link |
|---|---|
| US (5) | US8258962B2 (es) |
| EP (3) | EP2268261B1 (es) |
| JP (2) | JP2011513865A (es) |
| KR (1) | KR101661509B1 (es) |
| CN (2) | CN104376659B (es) |
| AU (1) | AU2009221781B2 (es) |
| CA (1) | CA2717862C (es) |
| DK (2) | DK2268261T3 (es) |
| ES (2) | ES2840773T3 (es) |
| IL (6) | IL207962A (es) |
| MY (1) | MY161533A (es) |
| PT (1) | PT3235491T (es) |
| SG (1) | SG188839A1 (es) |
| WO (1) | WO2009111664A2 (es) |
Families Citing this family (91)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2789262C (en) | 2005-04-28 | 2016-10-04 | Proteus Digital Health, Inc. | Pharma-informatics system |
| US9198608B2 (en) | 2005-04-28 | 2015-12-01 | Proteus Digital Health, Inc. | Communication system incorporated in a container |
| US20120004520A1 (en) * | 2005-04-28 | 2012-01-05 | Proteus Biomedical, Inc. | Communication System with Multiple Sources of Power |
| US8802183B2 (en) | 2005-04-28 | 2014-08-12 | Proteus Digital Health, Inc. | Communication system with enhanced partial power source and method of manufacturing same |
| US8912908B2 (en) | 2005-04-28 | 2014-12-16 | Proteus Digital Health, Inc. | Communication system with remote activation |
| US8730031B2 (en) | 2005-04-28 | 2014-05-20 | Proteus Digital Health, Inc. | Communication system using an implantable device |
| US20120024889A1 (en) * | 2005-04-28 | 2012-02-02 | Timothy Robertson | Polypharmacy Co-Packaged Medication Dosing Unit Including Communication System Therefor |
| US8836513B2 (en) | 2006-04-28 | 2014-09-16 | Proteus Digital Health, Inc. | Communication system incorporated in an ingestible product |
| AU2006251454A1 (en) * | 2005-05-24 | 2006-11-30 | Responsif Gmbh | Method for producing virus-type particles containing an active substance |
| US20140309505A1 (en) * | 2005-07-20 | 2014-10-16 | Etect, Inc | Electronic medication compliance monitoring system and associated methods |
| US8547248B2 (en) | 2005-09-01 | 2013-10-01 | Proteus Digital Health, Inc. | Implantable zero-wire communications system |
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| WO2008066617A2 (en) | 2006-10-17 | 2008-06-05 | Proteus Biomedical, Inc. | Low voltage oscillator for medical devices |
| KR101611240B1 (ko) | 2006-10-25 | 2016-04-11 | 프로테우스 디지털 헬스, 인코포레이티드 | 복용 가능한 제어된 활성화 식별자 |
| EP2069004A4 (en) | 2006-11-20 | 2014-07-09 | Proteus Digital Health Inc | PERSONAL HEALTH SIGNAL RECEIVERS WITH ACTIVE SIGNAL PROCESSING |
| US8858432B2 (en) | 2007-02-01 | 2014-10-14 | Proteus Digital Health, Inc. | Ingestible event marker systems |
| MY154556A (en) | 2007-02-14 | 2015-06-30 | Proteus Digital Health Inc | In-body power source having high surface area electrode |
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| US9270025B2 (en) | 2007-03-09 | 2016-02-23 | Proteus Digital Health, Inc. | In-body device having deployable antenna |
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| EP4011289A1 (en) | 2007-09-25 | 2022-06-15 | Otsuka Pharmaceutical Co., Ltd. | In-body device with virtual dipole signal amplification |
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